China-based SSY Group Ltd (HKG: 2005) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its stiripentol dry suspension, a drug used to treat Dravet syndrome. SSY’s product is confirmed to have passed the generic quality consistency evaluation (GQCE) process, marking a significant milestone in providing treatment options for patients with this rare condition.
Background on Stiripentol and Its Importance
Originally developed by Laboratoires Biocodex, stiripentol is a drug specifically designed for children with rare diseases. It was first approved in Europe in 2007 and in the US in 2018. SSY’s generic version of stiripentol, a Category III generic, was previously granted priority review status in China for use as an auxiliary treatment for refractory generalized tonic clonic seizures in Dravet syndrome patients whose seizures cannot be fully controlled by clobazam and valproate.
Market Implications and Availability
The originator product has not yet entered the Chinese market, making SSY’s generic stiripentol the only approved version of the molecule available in the country. This approval is crucial as it provides an alternative treatment option for patients suffering from Dravet syndrome, a severe form of epilepsy that requires specialized medication for effective management.-Fineline Info & Tech
